VITAL-KETODINE- chlorhexidine gluconate and ketoconazole shampoo

Vital-KetoDine by

Drug Labeling and Warnings

Vital-KetoDine by is a Animal medication manufactured, distributed, or labeled by Vital Animal Health, Custom Veterinary Services, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each dosage unit)                            Purpose

Chlorhexidine Gluconate 2% (w/w) ...….................................. antibacterial

Ketoconzaole 1% (w/w) ..…...................................................... antifungal

PURPOSE

Uses

A pleasantly scented shampoo with antiseptic activity (antibacterial and antifungal) designed for dogs, cats and horses with dermatological conditions responsive to chlorhexidine and ketoconazole.

WARNINGS AND PRECAUTIONS

Warnings
For Animal Use Only For topical use in dogs, cats, and horses Avoid contact with eyes or mucous membranes If eye contact occurs, rinse thoroughly with water and consult a veterinarian Not for otic use Wash hands after using Keep out of reach of children

DOSAGE & ADMINISTRATION

Directions
Wet the hair coat with warm water and apply a sufficient amount of Vital-KetoDine Shampoo. Massage shampoo into wet hair coat, lather freely. Allow shampoo to remain on hair for 5 to 10 minutes, then rinse thoroughly with clean water. Rinse and repeat. May be used initially 2 to 3 times a week for 4 weeks, then reducing to once a week, or as directed by your veterinarian.

STORAGE AND HANDLING

Other Information

Store at room temperature (59°F – 86°F)
Protect from freezing
Available only through licensed Veterinarians.

SPL UNCLASSIFIED SECTION

Vital-KetoDine Shampoo

Vital Animal Health
www.vitalanimalhealth.com

Manufactured in USA for:
Vital Animal Health
2031 Rand Ave.
Colorado Springs, CO 80905
800-344-1165

PRINCIPAL DISPLAY PANEL

Vital-KetoDine
Shampoo

for dogs, cats and horses
Chlorhexidine 2%, Ketoconazole 1%

Antiseptic shampoo in a synergistic base that offers deep cleansing and deodorizing properties

For mild to severe dermatologic conditions where a full-strength antimicrobial, antifungal, cleansing and deodorizing shampoo may be of benefit

16 FL OZ (474 ML)  or  1 GALLON (3.78 L)

MADE IN THE USA

INGREDIENTS AND APPEARANCE

VITAL-KETODINE 
chlorhexidine gluconate and ketoconazole shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 60255-333
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	20 mg  in 1 mL
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)	KETOCONAZOLE	10 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60255-333-16	474 mL in 1 BOTTLE, PLASTIC
2	NDC: 60255-333-28	3785 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/31/2013

Labeler - Vital Animal Health (003927150)

Registrant - Custom Veterinary Services, Inc. (619511483)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Veterinary Services, Inc.		619511483	manufacture